Predictors of Laparoscopy Conversion in Adhesive Small Bowel Obstruction

Almazov National Medical Research Centre

Status: Not yet enrolling

Conditions: Adhesive Small Bowel Obstruction

Treatments: Procedure: Laparotomic adhesiolysis; Procedure: Laparoscopic adhesiolysis

Study type: Observational

Funder types: Other

Identifiers

NCT07350447

14071979

Details and patient eligibility

About

The goal of this observational study is to reveal predictors of unsuccessfull laparoscopic intervention in adult patients with adhesive small bowel obstruction. The main question it aims to answer is: are there any strong predictors of laparoscopy conversion in patients with small bowel obstruction, caused by intraabdominal adhesions.

Full description

Considering the undeniable advantages of laparoscopic interventions over laparotomic ones, the question of choosing a surgical approach in patients with acute adhesive intestinal obstruction can be reformulated as follows: in what situations is endovideosurgical intervention generally appropriate and feasible? A laparoscopic approach to severely distended bowel loops and widespread adhesions may increase the risk of serious complications. Indeed, some authors report intestinal injury in 6.3-26.9% of patients undergoing laparoscopic adhesiolysis for acute adhesive intestinal obstruction, which is statistically significantly higher than the same rate in patients operated on using a traditional approach. Therefore, a priority should be addressing the issue of adequately selecting patients who, based on a number of clinical indicators, are suitable for laparoscopic surgery or, at least, have no contraindications. While some parameters, such as acute cardiovascular or respiratory failure and pregnancy in the third trimester, can be defined as absolute contraindications to endovideosurgical access, a number of clinical and instrumental indicators are debatable. Despite the fact that this issue has been extensively covered in the literature, and the list of predictors of unsuccessful laparoscopic adhesiolysis is currently quite impressive, a standardized approach to access selection is lacking or is determined largely intuitively.

The aim of this work is to determine reliable anamnestic, clinical and instrumental signs that would indicate a high risk of conversion of the laparoscopic intervention in patients with acute adhesive intestinal obstruction.

The study is planned to be a multicenter, retrospective case-control study. Clinical data will be collected at four medical institutions in St. Petersburg. The medical records of patients who underwent emergency and urgent surgery for acute adhesive intestinal obstruction will be analyzed.

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients underwent emergency and urgent surgery for acute adhesive intestinal obstruction
• the surgery was performed laparoscopically
• the surgery was initiated laparoscopically and completed via laparotomy

Exclusion criteria

• acute adhesive intestinal obstruction in the hernial sac
• pregnant in the third trimester
• patients with severe cardiovascular or respiratory failure
• patients with hemodynamic shock

Trial design

170 participants in 2 patient groups

Laparoscopy group

Description:

Patients with acute adhesive intestinal obstruction, operated through surgical intervention, that was initiated and completed using endovideosurgical methods.

Treatment:

Procedure: Laparoscopic adhesiolysis

Conversion group

Description:

Patients with acute adhesive intestinal obstruction, in whom surgical intervention was initiated by endovideosurgical means, however, during the operation there was a need for laparotomy and the surgical procedure was completed by laparotomy access.

Treatment:

Procedure: Laparotomic adhesiolysis